Evolut™ FX transcatheter aortic valve being deployed using the Evolut TAVR/TAVI implant procedure

Transcatheter Aortic Valve Implantation (TAVI)

Evolut™ TAVI implant procedure

with the cusp overlap technique

Delivering on ease of use through a more predictable and streamlined procedural experience

Indications, Safety, and WarningsIf you are located outside the United States, see the device manual. for detailed information regarding the Instructions for Use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI device, see the MRI technical manual before performing an MRI. For further information, contact your local Medtronic representative.For applicable products, consult instructions for use at www.medtronic.com/manuals. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.UC202502519a ML

Precision

Facilitate implant depth accuracy.

The cusp overlap view isolates the noncoronary cusp and elongates the left ventricular outflow tract. This provides a greater visual separation between the basal annular plane and the conduction system, and an accurate patient-specific anatomical view to assess and achieve target implant depth.¹

Control

Predictable valve deployment

Slow deployment starting from a supra-annular position allows the valve to descend to its target position, providing users with control over valve deployment and requiring minimal catheter manipulation. This minimizes the risk of interaction with the conduction system.

Optimize PRO FX Addendum analysis²

The cusp overlap technique with an optimized care pathway continues to show dependable clinical outcomes.^†

Accuracy when it matters most

Reproducible single-digit pacemaker rate: 6.7% PPI at 30 days
No ≥ moderate PVL (91% none/trace) at discharge
1 day median discharge
No patient-prosthesis mismatch (PPM) in > 93% of patients at discharge

Devices used: 100% Evolut™ FX. This is an expanded analysis of the Optimize PRO study of 146 patients receiving only the Evolut™ FX valve.

† This is an interim analysis of 400 main cohort patients. At the conclusion of the study, more than 650 patients will have been evaluated.

Real-world accuracy

Accurate depth assessment at the noncoronary cusp (NCC), facilitated with the cusp overlap technique, has resulted in single-digit pacemaker rates in several single-center and multicenter clinical studies.

Single-digit new 30-day permanent pacemaker implantation rates

1.5_%

Study 1
(n = 65)³
5.2_%

Study 2
(n = 134)⁴
5.7_%^‡

Study 3
(n = 105)⁵
4.6_%

Study 4
(n = 87)⁶
6.4_%

Study 5
(n = 156)⁷
6.7_%

Study 6
(n = 151)²

Excludes patients with baseline implantable cardioverter defibrillator or pacemaker.

‡ Discharge rates.

Explore the Evolut™ TAVI implant procedure on Medtronic Academy.

Find training modules, live cases, webinars, and more at your fingertips.

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Related products

Grubb JK, Gada H, Mittal S, et al. Clinical impact of standardized TAVR technique and care pathway: insights from the Optimize PRO study. JACC Cardiovasc Interv. 2023;16(5):558–570. doi: 10.1016/j.jcin.2023.01.016.
Gada HG, et al. Early outcomes from the Optimize PRO TAVR care pathway Evolut™ FX system addendum study. Presentation at SCAI, 2024.
Gada H. TAVR in low-risk patients. Presented at TVT 2019.
Gada H. Reduction of rates of permanent pacemaker implantation with 34 mm Evolut™ R using cusp overlap technique. Presented at TCT Connect 2020.
Gada H, et al. Reproducibility of cusp overlap technique to reduce permanent pacemaker implantation with Evolut™: the Latin American experience. Presented at TCT Connect 2020.
Pisaniello AD, Makki HBE, Jahangeer S, Daniels MJ, Hasan R, Fraser DGW. Low rates of permanent pacing are observed following self-expanding transcatheter aortic valve replacement using an annular plane projection for deployment. Circ Cardiovascular Interv. 2021;14(1):e009258. doi: 10.1161/CIRCINTERVENTIONS.120.009258.
Mendiz OA, Noč M, Fava CM, et al. Impact of cusp-overlap view for TAVR with self-expandable valves on 30-day conduction disturbances. J Interv Cardiol. 2021(28):9991528. doi: 10.1155/2021/9991528.

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